{"eventGroups":[{"description":"All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.","id":"EG000","otherNumAffected":31,"otherNumAtRisk":31,"seriousNumAffected":9,"seriousNumAtRisk":31,"title":"All Patients"}],"frequencyThreshold":"0","otherEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Blood disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":31,"numEvents":16}],"term":"Febrile neutropenia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Hemoglobin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Hemolysis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Lymph node pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Lymphatic disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Thrombotic microangiopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Atrial fibrillation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Atrial flutter"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Cardiac disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Left ventricular dysfunction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Left ventricular failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Pericardial effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pericarditis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Restrictive cardiomyopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Sinus bradycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":31,"numEvents":23}],"term":"Sinus tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Supraventricular tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Ventricular tachycardia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Ear disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"External ear inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Ear and labyrinth disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Middle ear inflammation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Cushingoid"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Endocrine disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Hyperthyroidism"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Dry eye syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Eye disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Eye pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Photophobia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Vision blurred"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Eye disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Watering eyes"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31,"numEvents":19}],"term":"Abdominal distension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":31,"numEvents":23}],"term":"Abdominal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Anal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Ascites"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Colonic hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31,"numEvents":9}],"term":"Constipation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":31,"numEvents":29}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Diarrhea associated with GVHD for BMT studies, if specified in the protocol."},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Dry mouth"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":31,"numEvents":12}],"term":"Dyspepsia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Dysphagia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":22,"numAtRisk":31,"numEvents":22}],"term":"Ear, nose and throat examination abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Esophageal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Esophagitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Fecal incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Flatulence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Gastritis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Gastrointestinal disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Gingival pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Hemorrhoids"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":31,"numEvents":18}],"term":"Mucositis oral"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":31,"numEvents":29}],"term":"Nausea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Oral hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Oral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Proctitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Rectal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Rectal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Upper gastrointestinal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":31,"numEvents":25}],"term":"Vomiting"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Chest pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":31,"numEvents":25}],"term":"Chills"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":31,"numEvents":25}],"term":"Edema limbs"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Facial pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":31,"numEvents":30}],"term":"Fatigue"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31,"numEvents":19}],"term":"Fever"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Flu-like symptoms"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Gait abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"General symptom"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Ill-defined disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Injection site reaction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Irritability"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8}],"term":"Localized edema"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":31,"numEvents":17}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Cytokine release syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Immune system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Hypersensitivity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Bladder infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Bronchitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Conjunctivitis infective"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Infectious colitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Lip infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Opportunistic infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Pancreas infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Paranasal sinus infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":31,"numEvents":15}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Sinusitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Skin infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Tracheitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Upper respiratory infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Urinary tract infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":31,"numEvents":14}],"term":"Bruising"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Dermatitis radiation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Intraoperative venous injury - Vein-portal vein"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Postoperative hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Radiation recall reaction (dermatologic)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Vascular access complication"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Injury, poisoning and procedural complications","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Wound dehiscence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Activated partial thromboplastin time prolonged"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":31,"numEvents":29}],"term":"Alanine aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":31,"numEvents":23}],"term":"Alkaline phosphatase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Amylase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":31,"numEvents":30}],"term":"Aspartate aminotransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Bilirubin increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Creatine phosphokinase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":21,"numAtRisk":31,"numEvents":21}],"term":"Creatinine increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Gamma-glutamyltransferase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Laboratory test abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Leukocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Lipase increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":31,"numEvents":26}],"term":"Lymphocyte count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Neutrophil count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Neutrophils/granulocytes (ANC/AGC) for BMT studies, if specified in the protocol."},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Platelet count decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":31,"numEvents":20}],"term":"Serum cholesterol increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Weight gain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Investigations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":31,"numEvents":17}],"term":"Weight loss"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Acidosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Alkalosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":26,"numAtRisk":31,"numEvents":26}],"term":"Anorexia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":31,"numEvents":20}],"term":"Blood bicarbonate decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Blood glucose increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Blood uric acid increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Dehydration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Iron overload"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":30,"numAtRisk":31,"numEvents":30}],"term":"Serum albumin decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Serum calcium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Serum calcium increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Serum glucose decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Serum magnesium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Serum magnesium increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":31,"numEvents":28}],"term":"Serum phosphate decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":29,"numAtRisk":31,"numEvents":29}],"term":"Serum potassium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Serum potassium increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":31,"numAtRisk":31,"numEvents":31}],"term":"Serum sodium decreased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Serum sodium increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Metabolism and nutrition disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":31,"numEvents":28}],"term":"Serum triglycerides increased"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":31,"numEvents":16}],"term":"Back pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Bone pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Buttock pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Joint pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":31,"numEvents":20}],"term":"Muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Muscle weakness lower limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Muscle weakness upper limb"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Musculoskeletal disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Myalgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Myositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31,"numEvents":9}],"term":"Neck pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Osteoporosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31,"numEvents":19}],"term":"Pain in extremity"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Depressed level of consciousness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":16,"numAtRisk":31,"numEvents":16}],"term":"Dizziness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Encephalopathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":27,"numAtRisk":31,"numEvents":27}],"term":"Headache"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Memory impairment"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Neuralgia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Neurological disorder NOS"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Nystagmus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Peripheral motor neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":10}],"term":"Peripheral sensory neuropathy"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Sinus pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Taste alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Nervous system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":9,"numAtRisk":31,"numEvents":9}],"term":"Tremor"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Agitation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":25,"numAtRisk":31,"numEvents":25}],"term":"Anxiety"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Confusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":31,"numEvents":12}],"term":"Depression"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":24,"numAtRisk":31,"numEvents":24}],"term":"Insomnia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Psychiatric disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Psychosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Bladder obstruction"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Bladder pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Bladder spasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Bladder stenosis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Cystitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Hemorrhage urinary tract"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Protein urine positive"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Urethral pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":7,"numAtRisk":31,"numEvents":7}],"term":"Urinary frequency"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Urinary incontinence"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Urinary retention"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Urogenital disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pelvic pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Perineal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Scrotal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Vaginal discharge"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Vaginal dryness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Vaginal hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Reproductive system and breast disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Vaginal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Allergic rhinitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8}],"term":"Atelectasis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Bronchopulmonary hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Bronchospasm"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":23,"numAtRisk":31,"numEvents":23}],"term":"Cough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31,"numEvents":19}],"term":"Dyspnea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Hemorrhage nasal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Hiccough"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8}],"term":"Hypoxia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":8,"numAtRisk":31,"numEvents":8}],"term":"Nasal congestion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pharyngeal examination abnormal"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pharyngeal mucositis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Pharyngolaryngeal pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":31,"numEvents":12}],"term":"Pleural effusion"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Pneumonitis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":31,"numEvents":5}],"term":"Respiratory disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":31,"numEvents":3}],"term":"Voice alteration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":18,"numAtRisk":31,"numEvents":18}],"term":"Alopecia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Decubitus ulcer"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":15,"numAtRisk":31,"numEvents":15}],"term":"Dry skin"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Hand-and-foot syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":12,"numAtRisk":31,"numEvents":12}],"term":"Petechiae"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":19,"numAtRisk":31,"numEvents":19}],"term":"Pruritus"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":28,"numAtRisk":31,"numEvents":28}],"term":"Rash desquamating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":10,"numAtRisk":31,"numEvents":10}],"term":"Skin disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":11,"numAtRisk":31,"numEvents":11}],"term":"Skin hyperpigmentation"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Skin ulceration"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Sweating"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Skin and subcutaneous tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Urticaria"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":14,"numAtRisk":31,"numEvents":14}],"term":"Flushing"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":6,"numAtRisk":31,"numEvents":6}],"term":"Hematoma"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":4,"numAtRisk":31,"numEvents":4}],"term":"Hemorrhage"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":20,"numAtRisk":31,"numEvents":20}],"term":"Hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":17,"numAtRisk":31,"numEvents":17}],"term":"Hypotension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Vascular disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Peripheral ischemia"}],"seriousEvents":[{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Blood and lymphatic system disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Blood disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Atrial flutter"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Cardiac disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Myocardial ischemia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Gastrointestinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Diarrhea"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Ill-defined disorder"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Multi-organ failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"General disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pain"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Hepatobiliary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Portal hypertension"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Abdominal infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Catheter related infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Colitis, infectious (e.g., Clostridium difficile)"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Opportunistic infection"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pneumonia"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Infections and infestations","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Sepsis"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Musculoskeletal and connective tissue disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Muscle weakness"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Renal and urinary disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":2,"numAtRisk":31,"numEvents":2}],"term":"Renal failure"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Adult respiratory distress syndrome"},{"assessmentType":"NON_SYSTEMATIC_ASSESSMENT","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"meddra10.0","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":31,"numEvents":1}],"term":"Pulmonary hemorrhage"}],"timeFrame":"180 days"}